Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...

The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that may not be biocompatible for use in ...

The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility issues medical device sponsors should consider in their premarket submissions. This is the second time the agency ...